CN109394987A - The composition and preparation method thereof with treatment eye disease containing dimethyl fumarate - Google Patents
The composition and preparation method thereof with treatment eye disease containing dimethyl fumarate Download PDFInfo
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- CN109394987A CN109394987A CN201811488555.XA CN201811488555A CN109394987A CN 109394987 A CN109394987 A CN 109394987A CN 201811488555 A CN201811488555 A CN 201811488555A CN 109394987 A CN109394987 A CN 109394987A
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- 208000030533 eye disease Diseases 0.000 title claims abstract description 41
- 238000002360 preparation method Methods 0.000 title claims abstract description 37
- LDCRTTXIJACKKU-ONEGZZNKSA-N dimethyl fumarate Chemical compound COC(=O)\C=C\C(=O)OC LDCRTTXIJACKKU-ONEGZZNKSA-N 0.000 title claims abstract description 27
- 229960004419 dimethyl fumarate Drugs 0.000 title claims abstract description 26
- 230000000694 effects Effects 0.000 claims abstract description 52
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- 235000008434 ginseng Nutrition 0.000 claims abstract description 30
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims abstract description 7
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract description 7
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
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- OJURWUUOVGOHJZ-UHFFFAOYSA-N methyl 2-[(2-acetyloxyphenyl)methyl-[2-[(2-acetyloxyphenyl)methyl-(2-methoxy-2-oxoethyl)amino]ethyl]amino]acetate Chemical compound C=1C=CC=C(OC(C)=O)C=1CN(CC(=O)OC)CCN(CC(=O)OC)CC1=CC=CC=C1OC(C)=O OJURWUUOVGOHJZ-UHFFFAOYSA-N 0.000 description 1
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- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/225—Polycarboxylic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/258—Panax (ginseng)
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/535—Perilla (beefsteak plant)
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- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
What the present invention relates to a kind of containing dimethyl fumarate has effects that treat the composition and preparation method thereof of eye disease, and have effects that the composition for the treatment of eye disease includes first chamber and second chamber: the component of first chamber includes: dimethyl fumarate and disodium ethylene diamine tetraacetate；Second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；Wherein, the mass ratio of first chamber and second chamber is 1:(0.4~0.6).The present invention is on the basis of the clinical experience of many years treatment ophthalmology disease, in conjunction with modern pharmacy achievement, by using the ginseng of different properties, Radix Glycyrrhizae and lophatherum gracile etc., have effects that treat ophthalmology disease with progress scientific compatibility, the compositions being prepared such as dimethyl fumarates, effect is obvious, it is quick, treating both manifestation and root cause of disease, there is no allergy or other reactions, will not bring side effect；Do not allow to be also easy to produce drug resistance, have a good application prospect.
Description
Technical field
The present invention relates to field of medicine preparing technology, and in particular to a kind of to have treatment eye disease containing dimethyl fumarate
The composition and preparation method thereof of sick effect.
Background technique
Eyes are the very important organ of human body and the most used one of the organ of human body, therefore do not pay attention to protecting,
It is easy to appear eye disease.The local bacterial sexuality dye of eye, including conjunctivitis, keratitis, ulcer of the cornea, iritis, eye wound
The diseases such as wound, chemical injury, ocular operation postoperative infection；Its pathogen is mostly pseudomonas aeruginosa and gram-positive cocci, such as epidermis Portugal
Grape coccus, staphylococcus saprophyticus, staphylococcus aureus and gonococcus etc., wherein staphylococcus epidermis account for the first.Conjunctiva inflammation
Shape is mostly acute onset, and simple eye, eyes all may illness, illness early stage, patient feels that eyes are hot, burns, photophobia, eye
Red, conscious eyes mill pain etc. feels particularly evident after getting up.And conjunctivitis has infectiousness more, slightly not note that resulting in week
There is symptom of similarly having an attack of one's old illness in the people enclosed.Keratitis is then often accompanied by apparent hypopsia and stronger irritation, ophthalmology inspection
Look into visible cornea gloss disappearance, transparency lowers, ulcer is formed, ciliary congestion.Serious patient's eye even occurs suppurating, burst
The apparent inflammation such as ulcer, there is very big damage to eyesight.The drug for the treatment of eye disease is various at present, although can temporarily improve eye
Portion's health problem, but after a period of use, it just will appear various side effects, it is possible to can cause to eye bigger
Damage；Or it is easy to produce drug resistance, keep low therapeutic benefit even invalid.Safe newtype drug is used therefore, it is also desirable to develop.
Summary of the invention
For the defects in the prior art, it is an object of that present invention to provide a kind of has treatment eye containing dimethyl fumarate
The composition and preparation method thereof of portion's disease effect, with many years treatment ophthalmology disease clinical experience on the basis of, in conjunction with the modern times
Pharmacy achievement carries out scientific compatibility with dimethyl fumarate etc. by using the ginseng of different properties, Radix Glycyrrhizae and lophatherum gracile etc.,
The composition being prepared has effects that treatment ophthalmology disease, and effect is obvious, and quick, treating both manifestation and root cause of disease, there is no allergy
Or other reactions, side effect will not be brought；Do not allow to be also easy to produce drug resistance, have a good application prospect.
To achieve the above object, technical solution provided by the invention are as follows:
Have effects that treat the composition of eye disease, including first chamber and the second combination the present invention provides a kind of
Object: the component of first chamber includes: dimethyl fumarate and disodium ethylene diamine tetraacetate；Second chamber be using ginseng,
Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile are prepared；Wherein, the mass ratio of first chamber and second chamber is 1:
(0.4~0.6).
In first chamber, the mass ratio of dimethyl fumarate and disodium ethylene diamine tetraacetate is 1:(0.05~0.1).
The preparation method of second chamber comprising steps of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla are put into ethanol water,
PH value is adjusted to 7.3~7.5, refluxing extraction is carried out later, is filtered after extraction, collect the first filtrate；Lophatherum gracile is used
Water carries out decoction extraction, filters after extraction, collects the second filtrate；First filtrate and the second filtrate are uniformly mixed, then
Smashed ginseng is added, adjusts pH value to 5.6~5.8 after impregnating preset time, ultrasonic extraction is carried out later, after extraction
Third filtrate is collected in filtering；Third filtrate is subjected to decolorization, the product after decolorization is concentrated into original volume
10%~12%, pH value is adjusted to 6.8~7.2, obtains second chamber.
Preferably, the mass ratio of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:(1.2~1.3): (0.1
~0.2): (0.05~0.07): (0.4~0.5): (2.3~2.8).
Preferably, the ratio of the quality of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, the gross mass of purple perilla and ethanol water be 1:(6~
9), the volume fraction of ethanol water is 55%~65%；The time of refluxing extraction is 150~160min.
Preferably, the mass ratio of lophatherum gracile and water is 1:(12~15), the time for decocting extraction is 30~40min.
Preferably, the time of immersion is 7~8h, and the temperature of immersion is 42~46 DEG C；The power of ultrasonic extraction be 300~
400W, the temperature of ultrasonic extraction are 30~40 DEG C, and the time of ultrasonic extraction is 6~8h.
The present invention also provides the preparation methods of the composition treat with eye disease, comprising steps of by first
The all components of composition are uniformly mixed, and second chamber is then added, is uniformly dispersed, sterilizes later, obtain having treatment eye
The composition of portion's disease effect.
The present invention also protects above-mentioned composition answering in the drug and/or medicated premix of preparation treatment eye disease
With.Ocular inflammatory disease includes and uveitis, conjunctivitis, cyclitis, sclerotitis, episcleritis, optic nerve be scorching, eyeball
Rear optic nerve inflammation, keratitis, blepharitis, ulcer of the cornea, conjunctival ulcer etc. in relation to or as its result and the eye that shows is scorching
Disease；By ocular inflammatory disease caused by eye disorders such as dry eyes, eye infection, optic nerve imbalance etc.；As caused by ophthalmologic operation
Ocular inflammatory disease；The ocular inflammatory disease as caused by the physical injury to eyes；The ocular inflammatory disease of unknown cause；By include itch, it is rubescent,
Symptom caused by the ocular inflammatory disease of oedema, ulcer etc..
It should be noted that the group with treatment ophthalmology disease containing dimethyl fumarate that the present invention is prepared
The application method for closing object is preferred are as follows: the composition being placed in eyedrops bottle shakes up, and takes and lies on the back or seat, head are faced upward later, eyes
It opens and looks up, lower eyelid is gently pulled down with index finger, or lower eyelid is pinched with thumb and index finger, eyedrops bottleneck is aligned
Eyes, for bottleneck apart from eyes probably at 2~3 centimetres, medicament for the eyes bottleneck, which should be avoided, touches eyelid, eyelashes or conjunctiva when dripping medicine, with
Prevent liquid medicine bottle from polluting；Composition should be dripped into the ditch between the eyelid and the white of the eye in outside, composition cannot be dripped
On iris；1 drop usually need to be only dripped every time；After dripping off, lift palpebra inferior gently up with thumb and index finger, be allowed to
Upper eyelid is harmonious, and most composition can be made to remain in the groove of palpebra inferior in this way, reduces the outflow of composition.
The composition of above method preparation can be further prepared into pharmaceutically acceptable dosage form as needed.In addition, with
Above-mentioned composition is that drug made of active constituent also belongs to protection scope of the present invention.By directly making above-mentioned composition
It is prepared after the standby or pharmaceutically acceptable auxiliary material of addition, can be made into any pharmaceutically acceptable dosage form.The medicine of various dosage forms
Object can be prepared according to the conventional method of pharmaceutical field.
Technical solution provided by the invention, with following the utility model has the advantages that (1) is provided by the invention to contain dimethyl fumarate
Have effects that treat eye disease composition, on the basis of being the clinical experience in Chinese medicine and western medicine eye disease, knot
The compound preparation of Integrated TCM for closing modern pharmacy achievement and developing, the present invention use the traditional Chinese medicine of different properties
Material has carried out the compatibility of science with Western medicine, and the composition being prepared has effects that treat eye disease, and effect is obvious, sees
Effect is fast, treating both manifestation and root cause of disease, and there is no allergy or other reactions, will not bring side effect；Do not allow to be also easy to produce drug resistance；(2) this hair
The composition treat with eye disease containing dimethyl fumarate of bright offer is less prone to substance after long-term place
Precipitation or lamination, with good stability and uniformity；(3) having containing dimethyl fumarate provided by the invention is controlled
The preparation method for treating the composition of eye disease effect, can sufficiently discharge the effective component in each raw material, so that preparation
Obtained composition possesses good effect, and is easy to absorb；Preparation method is simple, and production cost is low, may be implemented to industrialize
Production, it is boundless in field of ophthalmology market prospects.
Additional aspect and advantage of the invention will be set forth in part in the description, and will partially become from the following description
Obviously, or practice through the invention is recognized.
Specific embodiment
Below in conjunction with the embodiment of the present invention, technical solution of the present invention is clearly and completely described.Implement below
Example is only used for clearly illustrating technical solution of the present invention, therefore is intended only as example, and cannot be used as a limitation and limit this hair
Bright protection scope.
Experimental method in following embodiments is unless otherwise specified conventional method.Examination as used in the following examples
Material is tested, is to be commercially available from regular shops unless otherwise specified.Quantitative test in following embodiment, is respectively provided with three
Secondary to repeat to test, data are the average value or mean+SD of three repeated experiments.
The present invention provides a kind of composition with treatment eye disease, is 1:(0.4~0.6 including mass ratio)
First chamber and second chamber: the component of first chamber include mass ratio be 1:(0.05~0.1) fumaric acid diformazan
Ester and disodium ethylene diamine tetraacetate；Second chamber be using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile preparation and
At；
The preparation method of second chamber comprising steps of
Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla are put into the ethanol water that volume fraction is 55%~65%, adjust pH
To 7.3~7.5,150~160min of refluxing extraction, is filtered value after extraction later, collects the first filtrate；Wherein, Radix Glycyrrhizae, fish
The ratio of the quality of raw meat grass, lotus seeds, the gross mass of purple perilla and ethanol water is 1:(6~9)；
Lophatherum gracile is used into 30~40min of water boiling and extraction, is filtered after extraction, the second filtrate is collected；Wherein, henon bamboo
The mass ratio of leaf and water is 1:(12~15)；
First filtrate and the second filtrate are uniformly mixed, are then added smashed ginseng, after 42~46 DEG C of 7~8h of immersion
PH value is adjusted to 5.6~5.8, carries out ultrasonic extraction later, the power of ultrasonic extraction is 300~400W, the temperature of ultrasonic extraction
It is 30~40 DEG C, is filtered after extracting 6~8h, collects third filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and people
The mass ratio of ginseng is 1:(1.2~1.3): (0.1~0.2): (0.05~0.07): (0.4~0.5): (2.3~2.8)；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 10%~12% of original volume,
PH value is adjusted to 6.8~7.2, obtains second chamber.
In addition, the present invention also provides the preparation methods of the above-mentioned composition treat with eye disease, including such as
Lower step:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Has effects that treatment ophthalmology disease containing dimethyl fumarate to provided by the invention combined with specific embodiments below
Composition and preparation method thereof be described further.
Embodiment 1
Have effects that treat the composition of ophthalmology disease the present embodiment provides a kind of, is the first of 1:0.5 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.08
Acetic acid disodium；Second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
The preparation method of second chamber comprising steps of
By Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla be put into volume fraction be 60% ethanol water in, adjust pH value to
7.4, refluxing extraction 154min, is filtered after extraction later, collects the first filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla
Gross mass and ethanol water quality ratio be 1:7；
Lophatherum gracile is used into water boiling and extraction 36min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:13；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, is adjusted after 44 DEG C of immersion 7.5h
PH value carries out ultrasonic extraction, the power of ultrasonic extraction is 350W, and the temperature of ultrasonic extraction is 37 DEG C, after extracting 7h to 5.7 later
Third filtrate is collected in filtering；Wherein, the mass ratio of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:1.25:
0.14:0.06:0.46:2.6；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 11% of original volume, adjusts pH
Value obtains second chamber to 7.0.
By above-mentioned raw material, using preparation method provided by the invention, preparation has effects that treat the combination of ophthalmology disease
Object:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Embodiment 2
Have effects that treat the composition of ophthalmology disease the present embodiment provides a kind of, is the first of 1:0.4 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.05
Acetic acid disodium；Second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
The preparation method of second chamber comprising steps of
By Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla be put into volume fraction be 55% ethanol water in, adjust pH value to
7.3, refluxing extraction 150min, is filtered after extraction later, collects the first filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla
Gross mass and ethanol water quality ratio be 1:6；
Lophatherum gracile is used into water boiling and extraction 30min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:12；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, adjusts pH after 42 DEG C of immersion 7h
Value carries out ultrasonic extraction, the power of ultrasonic extraction is 300W, and the temperature of ultrasonic extraction is 30 DEG C, extracts mistake after 6h to 5.6 later
Third filtrate is collected in filter；Wherein, the mass ratio of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:1.2:0.1:
0.05:0.4:2.3；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 10% of original volume, adjusts pH
Value obtains second chamber to 6.8.
By above-mentioned raw material, using preparation method provided by the invention, preparation has effects that treat the combination of ophthalmology disease
Object:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Embodiment 3
Have effects that treat the composition of ophthalmology disease the present embodiment provides a kind of, is the first of 1:0.6 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.1
Acetic acid disodium；Second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
The preparation method of second chamber comprising steps of
By Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla be put into volume fraction be 65% ethanol water in, adjust pH value to
7.5, refluxing extraction 160min, is filtered after extraction later, collects the first filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla
Gross mass and ethanol water quality ratio be 1:(6~9)；
Lophatherum gracile is used into water boiling and extraction 40min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:15；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, adjusts pH after 46 DEG C of immersion 8h
Value carries out ultrasonic extraction, the power of ultrasonic extraction is 400W, and the temperature of ultrasonic extraction is 40 DEG C, extracts mistake after 8h to 5.8 later
Third filtrate is collected in filter；Wherein, the mass ratio of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:1.3:0.2:
0.07:0.5:2.8；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 12% of original volume, adjusts pH
Value obtains second chamber to 7.2.
By above-mentioned raw material, using preparation method provided by the invention, preparation has effects that treat the combination of ophthalmology disease
Object:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Comparative example 1
This comparative example provides a kind of composition with treatment ophthalmology disease, and the component of composition includes that mass ratio is
1:0.08 dimethyl fumarate and disodium ethylene diamine tetraacetate.
By above-mentioned raw material, preparation has effects that treat the composition of ophthalmology disease:
The all components of composition are uniformly mixed, are sterilized later, the composition for having effects that treat eye disease is obtained.
Comparative example 2
This comparative example provides a kind of composition with treatment ophthalmology disease, is the first of 1:0.5 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.08
Acetic acid disodium；Second chamber is prepared using ginseng, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
Cordate houttuynia, lotus seeds, purple perilla are put into the ethanol water that volume fraction is 60%, adjusting pH value to 7.4, later
Refluxing extraction 154min is filtered after extraction, collects the first filtrate；Wherein, cordate houttuynia, lotus seeds, purple perilla gross mass and second
The ratio of the quality of alcohol solution is 1:7；
Lophatherum gracile is used into water boiling and extraction 36min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:13；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, is adjusted after 44 DEG C of immersion 7.5h
PH value carries out ultrasonic extraction, the power of ultrasonic extraction is 350W, and the temperature of ultrasonic extraction is 37 DEG C, after extracting 7h to 5.7 later
Third filtrate is collected in filtering；Wherein, the mass ratio of cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1.25:0.14:0.06:
0.46:2.6；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 11% of original volume, adjusts pH
Value obtains second chamber to 7.0.
By above-mentioned raw material, preparation has effects that treat the composition of ophthalmology disease:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Comparative example 3
This comparative example provides a kind of composition with treatment ophthalmology disease, is the first of 1:0.5 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.08
Acetic acid disodium；Second chamber is prepared using ginseng, Radix Glycyrrhizae, lotus seeds, purple perilla and lophatherum gracile；
The preparation method of second chamber comprising steps of
Radix Glycyrrhizae, lotus seeds, purple perilla are put into the ethanol water that volume fraction is 60%, adjust pH value to 7.4, return later
Stream extracts 154min, filters after extraction, collects the first filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla gross mass and
The ratio of the quality of ethanol water is 1:7；
Lophatherum gracile is used into water boiling and extraction 36min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:13；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, is adjusted after 44 DEG C of immersion 7.5h
PH value carries out ultrasonic extraction, the power of ultrasonic extraction is 350W, and the temperature of ultrasonic extraction is 37 DEG C, after extracting 7h to 5.7 later
Third filtrate is collected in filtering；Wherein, the mass ratio of Radix Glycyrrhizae, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:0.14:0.06:0.46:
2.6；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 11% of original volume, adjusts pH
Value obtains second chamber to 7.0.
By above-mentioned raw material, using preparation method provided by the invention, preparation has effects that treat the combination of ophthalmology disease
Object:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
Comparative example 4
This comparative example provides a kind of composition with treatment ophthalmology disease, is the first of 1:0.5 including mass ratio
Composition and second chamber: the component of first chamber includes the dimethyl fumarate and ethylenediamine tetraacetic that mass ratio is 1:0.08
Acetic acid disodium；Second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
The preparation method of second chamber comprising steps of
By Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla be put into volume fraction be 60% ethanol water in, adjust pH value to
7.4, refluxing extraction 154min, is filtered after extraction later, collects the first filtrate；Wherein, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla
Gross mass and ethanol water quality ratio be 1:7；
Lophatherum gracile is used into water boiling and extraction 36min, is filtered after extraction, the second filtrate is collected；Wherein, lophatherum gracile and
The mass ratio of water is 1:13；
First filtrate and the second filtrate are uniformly mixed, smashed ginseng is then added, 44 DEG C are impregnated the laggard of 7.5h
Row ultrasonic extraction, the power of ultrasonic extraction are 350W, and the temperature of ultrasonic extraction is 37 DEG C, is filtered after extracting 7h, collect third filter
Liquid；Wherein, the mass ratio of Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla, lophatherum gracile and ginseng is 1:1.25:0.14:0.06:0.46:
2.6；
Third filtrate is subjected to decolorization, the product after decolorization is concentrated into the 11% of original volume, adjusts pH
Value obtains second chamber to 7.0.
By above-mentioned raw material, using preparation method provided by the invention, preparation has effects that treat the combination of ophthalmology disease
Object:
The all components of first chamber are uniformly mixed, second chamber is then added, are uniformly dispersed, are sterilized later,
Obtain the composition for having effects that treat eye disease.
There is treatment eye disease function containing dimethyl fumarate by what the embodiment of the present invention 1 to embodiment 3 was prepared
The composition of effect is evaluated its effect by function assessment test, and contains fumaric acid with what comparative example 1 to comparative example 4 was prepared
The composition treat with eye disease of dimethyl ester is as control.
1, bacteriostatic test
The tool containing dimethyl fumarate that the embodiment of the present invention 1 to embodiment 3, comparative example 1 to comparative example 4 are prepared
There is the composition for the treatment of eye disease effect to be serially diluted with the agar medium that has melted, by composition concentration dilution 2,4,
8,16,32 times, the plating medium of the drug concentration of extension rate containing different components is poured into.It sets simultaneously and medical fluid is not added and containing blueness
Plating medium each one of mycin, streptomysin makees the control of bacterium normal growth and positive drug control respectively.By inoculation test
The plate of bacterium solution sets culture 24 hours in 37 DEG C of incubators, observes and records each bacterial strain in the growth feelings of different pharmaceutical concentration cultures
Condition.The present composition indicates the external of drug with it using the minimum inhibitory concentration (MIC) of coubling dilution measurement eye drops
Antibacterial intensity.
Test result is as shown in table 1.
Table 1 is different to organize other composition extracorporeal bacteria inhibitor test result
Note: "-" is no bacterial growth, and "+" is to have bacterial growth.
2, clinical effectiveness
90 eye (conjunctivitis) patients (25~50 years old) are recruited, are divided into 3 groups, there was no significant difference between each group, clinical
Symptom: eyes are hot, burn, photophobia, are envious, and conscious eyes mill pain is often accompanied by apparent hypopsia and stronger stimulation disease
Shape.The composition drop treat with eye disease containing dimethyl fumarate that embodiment 1-3 is prepared is respectively adopted
Eye, one time 1 drop observe curative effect three times a day.
Efficacy assessment standard: efficacy assessment standard is formulated referring to " traditional Chinese medicine Clinical Researches of New Drugs guideline ": being cured: being faced
Bed symptom and sign disappears；Effective: Clinical symptom and sign substantially or mostly disappears；Effective: Clinical symptom and sign has mitigation or slow
Solution；Invalid: Clinical symptom and sign is without improvement.
Experimental result: Most patients are using drug 3 days or so symptoms substantially reduced according to the method for the present invention, and 7 days
Eyes are hot afterwards, burn, photophobia, furious, the conscious most of disappearance of eyes mill pain, and concrete outcome is as shown in table 2 below.All trouble
Adverse reaction and toxic side effect are not found during person's use.
2 effect statistical form of table
| Group | Recovery from illness | It is effective | Effectively | In vain |
| Embodiment 1 | 18 | 10 | 2 | 0 |
| Embodiment 2 | 17 | 10 | 3 | 0 |
| Embodiment 3 | 17 | 11 | 2 | 0 |
It should be noted that unless otherwise indicated, technical term or scientific term used in this application should be this hair
The ordinary meaning that bright one of ordinary skill in the art are understood.Unless specifically stated otherwise, it otherwise illustrates in these embodiments
Component and opposite step, numerical expression and the numerical value of step are not limit the scope of the invention.It is illustrated and described herein
In all examples, unless otherwise prescribed, any occurrence should be construed as merely illustratively, not as limitation, because
This, other examples of exemplary embodiment can have different values.
In the description of the present invention, it is to be understood that, term " first ", " second " are used for description purposes only, and cannot
It is interpreted as indication or suggestion relative importance or implicitly indicates the quantity of indicated technical characteristic.Define as a result, " the
One ", the feature of " second " can explicitly or implicitly include one or more of the features.In the description of the present invention,
The meaning of " plurality " is two or more, unless otherwise specifically defined.
Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Pipe present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: its according to
So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into
Row equivalent replacement；And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme should all cover in protection scope of the present invention.
Claims (10)
1. a kind of have effects that treat the composition of eye disease, it is characterised in that:
Including first chamber and second chamber:
The component of the first chamber includes: dimethyl fumarate and disodium ethylene diamine tetraacetate；
The second chamber is prepared using ginseng, Radix Glycyrrhizae, cordate houttuynia, lotus seeds, purple perilla and lophatherum gracile；
Wherein, the mass ratio of the first chamber and the second chamber is 1:(0.4~0.6).
2. according to claim 1 have effects that treat the composition of eye disease, it is characterised in that:
In the first chamber, the mass ratio of the dimethyl fumarate and the disodium ethylene diamine tetraacetate is 1:(0.05
~0.1).
3. according to claim 1 have effects that treat the composition of eye disease, which is characterized in that
The preparation method of the second chamber comprising steps of
Radix Glycyrrhizae, cordate houttuynia, lotus seeds and purple perilla are put into ethanol water, pH value is adjusted to 7.3~7.5, flows back later
It extracts, is filtered after extraction, collect the first filtrate；
Lophatherum gracile is subjected to decoction extraction using water, is filtered after extraction, collects the second filtrate；
First filtrate and second filtrate are uniformly mixed, smashed ginseng is then added, after impregnating preset time
PH value is adjusted to 5.6~5.8, ultrasonic extraction is carried out later, is filtered after extraction, collect third filtrate；
By the third filtrate carry out decolorization, by the product after the decolorization be concentrated into original volume 10%~
12%, pH value is adjusted to 6.8~7.2, obtains the second chamber.
4. according to claim 3 have effects that treat the composition of eye disease, it is characterised in that:
The Radix Glycyrrhizae, the cordate houttuynia, the lotus seeds, the purple perilla, the lophatherum gracile and the ginseng mass ratio be 1:
(1.2~1.3): (0.1~0.2): (0.05~0.07): (0.4~0.5): (2.3~2.8).
5. according to claim 3 have effects that treat the composition of eye disease, it is characterised in that:
The Radix Glycyrrhizae, cordate houttuynia, lotus seeds, the gross mass of purple perilla and the ethanol water the ratio of quality be 1:(6~9),
The volume fraction of the ethanol water is 55%~65%；
The time of the refluxing extraction is 150~160min.
6. according to claim 3 have effects that treat the composition of eye disease, it is characterised in that:
The mass ratio of the lophatherum gracile and water is 1:(12~15), the time for decocting extraction is 30~40min.
7. according to claim 3 have effects that treat the composition of eye disease, it is characterised in that:
The time of the immersion is 7~8h, and the temperature of the immersion is 42~46 DEG C；
The power of the ultrasonic extraction is 300~400W, and the temperature of the ultrasonic extraction is 30~40 DEG C, the ultrasonic extraction
Time is 6~8h.
8. the preparation method of the described in any item compositions treat with eye disease of claim 1-7, feature exist
In, comprising steps of
The all components of the first chamber are uniformly mixed, the second chamber is then added, is uniformly dispersed, goes out later
Bacterium obtains the composition with treatment eye disease.
9. the described in any item compositions of claim 1-7 are in the drug and/or medicated premix of preparation treatment eye disease
Application.
10. application according to claim 9, it is characterised in that:
The eye disease includes: conjunctivitis, cyclitis, sclerotitis, episcleritis, optic nerve inflammation, retrobulbar view
Feel neuritis, keratitis, blepharitis, ulcer of the cornea, dry eyes, eye infection.
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